Manufactured with the application of originally designed aseptic filling technology to meet the highest quality standards. USP and pharmacopeia class raw materials used for manufacturing in the GMP certified manufacturing site. We offer CE class III product certified by TUV Nord having shelf life of 12 months, that can be stored at temperatures between 2 and 15 Celsius, packed in EVA bags. Our bags are optimised for organs’ perfusion – equipped with high flow spike port injection port and available in 1 and 2 liter volume.
PlegiStore® (1000 ml / 2000 ml)
Medical devices for professional user
Histidine-Tryptophan-Ketoglutarate (HTK formula) solution.
Composition:
| sodium chloride | 0.8766 g | 15.0 mmol/L |
| potassium chloride | 0.6710 g | 9.0 mmol/L |
| magnesium chloride · 6 H2O | 0.8132 g | 4.0 mmol/L |
| histidine hydrochloride · H2O | 3.7733 g | 18.0 mmol/L |
| histidine | 27.9289 g | 180.0 mmol/L |
| tryptophan | 0.4085 g | 2.0 mmol/L |
| mannitol | 5.4651 g | 30.0 mmol/L |
| calcium chloride · 2 H2O | 0.0022 g | 0.015 mmol/L |
| potassium hydrogen 2-oxopentandioate (synonym: potassium hydrogen 2-ketoglutarate) | 0.1842 g | 1.0 mmol/L |
| Potassium hydroxide 2N to pH adjustment | q.s. | |
| Water for injection | q.s. 1.000 mL |
Storage Conditions:
| Shelf Life | 12 Months |
| Temperature | 2°C to 15°C, Do not Freeze |
PlegiStore® perfusion solution is a clear, transparent to slightly yellow, sterile, non-pyrogenic, non-toxic solution designed for hypothermic flushing and in vitro storage of implanted organ. The solution has an approximate calculated osmolality of 310 mOsm/kg and a pH of approximately 7,02 – 7,20 at room temperature and 7,40 – 7,45 at +4oC.
